FDA approves Northera

SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension.

NOH is a rare, chronic drop in blood pressure upon standing that's associated with Parkinson's disease, multiple-system atrophy and pure autonomic failure. Symptoms include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands.

“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH, and we are committed to helping make safe and effective treatments available.”

Northera received orphan-product designation from the FDA; it is made by Charlotte-based Chelsea Therapeutics.

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